Recurrent Thyroid Cancer Clinical Trial
Official title:
Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine
Verified date | October 2018 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.
Status | Completed |
Enrollment | 12 |
Est. completion date | May 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed papillary thyroid or follicular thyroid carcinoma: - Differentiated disease; - Metastatic disease documented by ultrasound, computed tomography (CT) scan (without iodinated contrast), or MRI - All metastatic disease foci =< 10 mm in all dimensions - Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan - Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks: - Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan - Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L - No known brain metastases - Performance status: - Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100% - Hematopoietic: - Absolute neutrophil count >= 1,500/mm3; - Platelet count >= 100,000/mm3; - White Blood Count (WBC) >= 3,000/mm3 - Hepatic: - aspartate aminotransferase-alanine aminotransferase (AST and ALT) =< 2.5 times upper limit of normal; - Bilirubin normal - Renal: - Creatinine not elevated OR - Creatinine clearance >= 60 mL/min - Cardiovascular: - No symptomatic congestive heart failure; - No unstable angina pectoris; - No cardiac arrhythmia - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction attributed to compounds of similar chemical or biological composition to decitabine - No concurrent uncontrolled illness - No active or ongoing infection - No psychiatric illness or social situation that would preclude study compliance - No prior cytotoxic chemotherapy for thyroid cancer - At least 6 months since prior external beam radiotherapy administered for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph node regions (no more than 6,000 cGy) - More than 6 months since other prior radiotherapy and recovered - More than 6 months since prior therapeutic 131I > 10 mCi - More than 18 months since prior cumulative 131I activity of at least 500 mCi - More than 12 months since prior amiodarone (Unless 24-hour urinary iodine excretion is =< 500 mcg) - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent anticancer therapy - No other concurrent investigational agents - More than 6 months since prior intrathecal iodinated contrast (Unless 24-hour urinary iodine excretion is =< 500 mcg) - More than 3 months since prior IV or oral iodinated contrast for radiographic studies (Unless 24-hour urinary iodine excretion is =< 500 mcg) |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado at Denver | Aurora | Colorado |
United States | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio |
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration | Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine. Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera. |
Week 3 following 2 weeks of Decitabine therapy | |
Secondary | Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Summary of Adverse Events (AEs) by Maximum Grade where Grade 1 AEs >20%, Grade 2 AEs >10%, all Grade 3, Grade 4 and Grade 5 reported. | Up to 6 months | |
Secondary | Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease. | Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | 6 months | |
Secondary | Change in Fludeoxyglucose (FDG) Uptake Measured by Positron Emission Tomography in Metastatic Tumor Sites Before and After DNA-methyltransferase Inhibitor Therapy (Optional). No Secondary Endpoints Were Measured as no Patient Met the Primary Endpoint. | Baseline to 3 weeks | ||
Secondary | Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease | Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. | 3 months | |
Secondary | Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level | 6 months | ||
Secondary | Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level.These Secondary Endpoints Would Only Have Been Assessed if a Patient Had Met the Primary Endpoint, Restoration of Radioiodine Uptake to Justify Radioiodine Therapy. | 3 months |
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